Top-Line Results for Plecanatide in Chronic Idiopathic Constipation Trial

Synergy Pharmaceuticals announced positive results from the first of two Phase 3 clinical trials evaluating the efficacy and safety of plecanatide 3mg and 6mg treatment doses in patients with chronic idiopathic constipation (CIC).

The first clinical trial in the Phase 3 CIC program is a randomized, 12-week, double-blind, placebo-controlled trials evaluating the efficacy and safety of plecanatide in 1,346 adults. Both trials include a two-week pre-treatment baseline period, a 12-week treatment period, and a two-week post-treatment period. Patients were randomly assigned to take 3mg or 6mg plecanatide or placebo once-a-day during the 12 week treatment period. The primary endpoint for both trials is the proportion of durable overall responders (%).

RELATED: Movantik for Opioid-Induced Constipation Launched

Preliminary analysis of the data indicates that both plecanatide 3mg and 6mg doses met the study's primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (21.0% in 3mg and 19.5% in 6mg dose groups compared to 10.2% in placebo; P<0.001 for both doses).

For more information visit SynergyPharma.com.

Loading links....